Coronary Artery Disease (CAD)MICRA-HYBRIDNCT07314138
Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronary Artery Bypass Grafting
A study testing Multivessel Hybrid Coronary Revascularization and Off-pump coronary arterial bypass grafting (OPCAB) in people with Coronary Artery Disease (CAD) and Bypass, Cardiopulmonary, run by Catharina Ziekenhuis Eindhoven at 2 sites in 2 countries.
Trial summary
The MICRA-HYBRID trial is a prospective, multicenter, randomized controlled study comparing multivessel hybrid coronary revascularization (HCR) as minimally invasive arterial bypass grafting to left-sided coronary targets (LAD and LCx) plus PCI of the RCA versus conventional off-pump coronary artery bypass grafting… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease (CAD), Bypass, Cardiopulmonary, Minimally Invasive Coronary Revascularization Surgery
- What is being tested?
- Multivessel Hybrid Coronary Revascularization and Off-pump coronary arterial bypass grafting (OPCAB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Aug 2026to 1 May 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with three-vessel disease (either angiographic stenoses >70% or a fractional flow reserve value ≤0.80)
- Left main diameter stenosis ≥50% or a left main intravascular ultrasound minimal luminal area of ≤4.5 mm2 or fractional flow reserve value ≤0.80 combined with significant CAD of the right coronary artery
Who cannot join
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Age < 18 or > 85 years
- Chronic total occlusion of the RCA
- In-stent RCA restenosis
- RCA stenosis with high-risk clinical features requiring urgent PCI or surgical revasculari-zation.
- Reverse hybrid coronary revascularization, defined as PCI-RCA followed by surgical re-vascularization.
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- Acute cardiac ischemia necessitating immediate intervention.
- EF < 30 %
- eGFR < 30 ml/min
- Indication for concomitant cardiac surgery (e.g. valve or arrhythmia surgery) or non-cardiac surgery
- Previous thoracic or cardiac surgery, mediastinal irradiation, significant trauma to the chest
- Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure) or cancer.
- Hemodynamically significant left subclavian stenosis
- Severe chest wall deformities
- History of pericarditis
- Body mass index > 40 Kg/m2.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vlaams Brabant, 3000
Wouter Oosterlinck, Prof. Dr. MD, PhD, +32 16 33 22 11, wouter.oosterlinck@uzleuven.be
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Hospital Eindhoven
Eindhoven, Eindhoven, 5623 EJ
Ferdi Akca, MD, PhD, +31 40 239 9111, ferdi.akca@catharinaziekenhuis.nl
Ismail Cenik, MD, +31 40 239 9111, ismail.cenik@catharinaziekenhuis.nl
About this study
Official title: MICRA-HYBRID Trial: A Randomized Controlled Trial of 'Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-Pump Coronary Artery Bypass Grafting'
The MICRA-HYBRID trial is a prospective, multicenter, randomized controlled study comparing multivessel hybrid coronary revascularization (HCR) as minimally invasive arterial bypass grafting to left-sided coronary targets (LAD and LCx) plus PCI of the RCA versus conventional off-pump coronary artery bypass grafting (OPCAB) via median sternotomy in patients with three-vessel coronary artery disease. The primary goal is to evaluate whether multivessel-HCR provides superior 30-day "textbook" clinical outcomes (mortality, MI, stroke, re-exploration for bleeding, and other complications) while improving perioperative recovery and long-term cardiovascular outcomes.
Read the detailed description
Coronary artery disease remains the leading cause of cardiovascular mortality worldwide. For complex, multivessel disease, surgical revascularization via CABG or OPCAB remains the guideline-recommended standard due to superior long-term outcomes compared with PCI alone. However, traditional sternotomy CABG/OPCAB is associated with significant surgical trauma, prolonged recovery, and elevated perioperative morbidity.
Minimally invasive coronary surgery (MICS) with off-pump arterial grafting through a small thoracotomy has shown favorable short-term recovery and lower morbidity in both single and multivessel disease cases. Traditionally, MICS has been limited to grafting the left anterior descending artery (LAD), with other coronary lesions treated by PCI, known as hybrid coronary revascularization (HCR). While most studies have focused on single-vessel HCR (typically LAD), the potential long-term benefits of including the circumflex (Cx) artery in a multivessel-HCR strategy remain unexplored. Given that three-vessel CAD is the most common indication for CABG, evaluating a multivessel-HCR approach (LAD + Cx via MICS, RCA via PCI) is essential.
The MICRA-HYBRID trial will randomize 250 patients with three-vessel coronary disease eligible for complete revascularization to either multivessel-HCR or conventional total-arterial OPCAB (median sternotomy, anaortic, off-pump). The primary efficacy endpoint is a composite "Textbook Outcome" at 30 days, defined by absence of death, MI, stroke, re-exploration for bleeding, and other major complications. Secondary endpoints include individual components of the Textbook Outcome, perioperative recovery parameters (ICU/hospital length of stay, ventilator time, transfusion requirement), health-related quality of life (EQ-5D), pulmonary recovery metrics, angina class (CCS), and long-term outcomes including MACCE and target-vessel revascularization up to five years.
- Conditions
- Coronary Artery Disease (CAD), Bypass, Cardiopulmonary, Minimally Invasive Coronary Revascularization Surgery, Off-pump Coronary Artery Bypass
- Being tested
- Multivessel Hybrid Coronary Revascularization, Off-pump coronary arterial bypass grafting (OPCAB)
- Keywords
- minimally invasive coronary surgery, percutaneous coronary intervention, off-pump coronary artery bypass grafting, hybrid coronary revascularization, heart surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivessel Hybrid Coronary RevascularizationProcedure or surgery
Multivessel-HCR consists of MICS revascularization of the left sided coronary vessels (LAD , Cx) combined with PCI for the RCA during the same admission or within 4 weeks postoperatively. Surgical revascularization is performed through MICS which consists of either robotically or non-robotically assisted thoracoscopic IMA harvesting followed by total arterial off-pump anastomosis of the grafts through a left anterior 3-5 cm mini-thoracotomy. PCI will be performed via radial or femoral access according to local routine and is restricted to the RCA.
Off-pump coronary arterial bypass grafting (OPCAB)Procedure or surgery
OPCAB will be performed as per clinical routine at each center through a median sternotomy. IMA harvesting (pedicled or skeletonised) follows each center's routine. An anaortic, total arterial strategy with a LIMA-LAD graft and complete revascularisation is obliged.
| Study group | Role | What they receive |
|---|---|---|
| Multivessel hybrid coronary revascularization (HCR) | Active comparator | Minimally invasive coronary artery bypass surgery to the left sided coronary vessels combined with percutaneous coronary intervention to the right coronary artery. Receives: Procedure: Multivessel Hybrid Coronary Revascularization |
| Off-pump coronary artery bypass grafting (OPCAB) | Active comparator | Total arterial, anaortic off-pump ccoronary artery bypass grafting through median sternotomy. Receives: Procedure: Off-pump coronary arterial bypass grafting (OPCAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Absence of Adverse Events within 30 Days Postoperatively (Textbook Outcome)
The primary endpoint is defined as the "Textbook Outcome," which is the composite absence, within 30 days postoperatively, of the following events:
- Mortality
- Re-exploration for bleeding
- Postoperative ischemia (requiring bypass grafting or acute PCI)
- Postoperative myocardial infarction (type 5 MI according to the fourth universal definition of myocardial infarction)
- Cardiac tamponade (requiring surgical or percutaneous intervention)
- Cerebrovascular accident / transient ischemic attack
- Wound infection requiring antibiotics or intervention
- New-onset atrial fibrillation requiring medical anti-thrombotic therapy
- Pneumonia requiring IV or oral antibiotics
- Placement of additional chest drains
- Prolonged hospital stay (> 7 days) after surgery
Measured: 30 days postoperatively
Secondary outcomes (15)
Conversion to Sternotomy
Rate of conversion to sternotomy for minimally invasive coronary surgery (MICS) patients.
Measured: Peri-operatively
Conversion to Cardiopulmonary Bypass
Incidence of hemodynamic support with cardiopulmonary bypass during the surgical procedures.
Measured: Peri-operatively
Intensive Care Unit (ICU) Stay
Duration of ICU stay following the surgical procedure (in days).
Measured: 30 days postoperatively
Postoperative Hospital Stay
Total length of postoperative hospital stay (in days).
Measured: 30 days postoperatively
Mechanical Ventilation Time
Total ventilation time during the postoperative period (in hours).
Measured: 30 days postoperatively
Postoperative Blood Loss
Total volume of postoperative blood loss (in milliliters) postoperatively.
Measured: 30 days postoperatively
Transfusion Requirement
Need for transfusion of blood products (packed units of thrombocyt, red blood cells and plasma) during the postoperative period
Measured: 30 days postoperatively
Phrenic Nerve Injury
Incidence of phrenic nerve injury leading to diaphragm paralysis.
Measured: 30 days postoperatively
Postoperative Peak Expiratory Flow (PEF)
PEF measurement at Day 1 and Day 3 postoperatively, and at 4 weeks post-discharge.
Measured: 30 days postoperatively
Quality of Life Assessment (EQ-5D)
Quality of life assessment using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline (screening), 2 weeks and 4 weeks postoperatively and at 12 months follow-up
Measured: 1 year
Angina Assessment (CCS Classification)
Assessment of angina using the Canadian Cardiovascular Society (CCS) classification at baseline, discharge and every 3 months for up to 1 year
Measured: 1 year
Short-term Healthcare Costs
Healthcare costs associated with hospitalization within 30 days postoperatively (in euros), including expenses for surgical and percutaneous procedures, diagnostic tests, ICU care, nursing days, reinterventions, complications, and post-discharge admissions (e.g., emergency visits, re-admissions, primary care consultations).
Measured: 30 days
Long-term Healthcare Costs
Healthcare costs within 1 year postoperatively (in euros), including expenses for diagnostic tests, reinterventions, emergency visits, re-admissions, primary care consultations, repeat visits, telephone, video, and written consultations, as well as after-hours urgent care (e.g., on-call GP visits).
Measured: 1 year
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Incidence of MACCE including mortality, stroke and myocardial infarction up to 5 years post-procedure.
Measured: 5 years
Target Vessel Revascularization (TVR)
Incidence TVR up to 5 years post-procedure.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start25 Aug 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dual center, superiority, randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Eindhoven University of Technology
- Responsible party
- Principal investigator, Ferdi Akca, Catharina Ziekenhuis Eindhoven
- Investigators
- Ferdi Akca, MD, PhD, Principal investigator, Catharina Ziekenhuis EindhovenWouter Oosterlinck, Prof. Dr. MD, PhD, Study chair, Universitaire Ziekenhuizen KU LeuvenPim Tonino, Prof. Dr. MD, PhD, Study chair, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314138
- Sponsor's protocol ID
- NL-010448
- Acronym
- MICRA-HYBRID
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD could be made available upon request to the Principal Investigator after the study's completion.
Publications
van Steenbergen GJ, Schulz DN, Slingerland SR, Tonino PA, Soliman-Hamad MA, Dekker L, van Veghel D. Introduction of a New Method to Monitor Patient-Relevant Outcomes and Costs: Using a Quality Improvement Project in Transcatheter Aortic Valve Implantation Care as an Example. Qual Manag Health Care. 2023 Oct-Dec 01;32(4):247-256. doi: 10.1097/QMH.0000000000000401. Epub 2023 Mar 16.
PubMed 36940366Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction; Authors/Task Force Members Chairpersons; Thygesen K, Alpert JS, White HD; Biomarker Subcommittee; Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA; ECG Subcommittee; Chaitman BR, Clemmensen PM, Johanson P, Hod H; Imaging Subcommittee; Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ; Classification Subcommittee; Fox KA, Atar D, Newby LK, Galvani M, Hamm CW; Intervention Subcommittee; Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J; Trials & Registries Subcommittee; Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML; Trials & Registries Subcommittee; Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G; Trials & Registries Subcommittee; Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D; Trials & Registries Subcommittee; Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG); Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S; Document Reviewers; Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012 Oct 16;60(16):1581-98. doi: 10.1016/j.jacc.2012.08.001. Epub 2012 Sep 5. No abstract available.
PubMed 22958960Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.
PubMed 30153967Modrau IS, Nielsen PH, Nielsen DV, Christiansen EH, Hoffmann T, Parner ET, Benhassen LL. Outcome of hybrid compared to conventional revascularization in multivessel coronary artery disease. Scand Cardiovasc J. 2020 Dec;54(6):376-382. doi: 10.1080/14017431.2020.1821910. Epub 2020 Sep 30.
PubMed 32998590Halkos ME, Ford L, Peterson D, Bluestein SM, Liberman HA, Kilgo P, Puskas JD, Guyton RA, Chowdhury R. The impact of hybrid coronary revascularization on hospital costs and reimbursements. Ann Thorac Surg. 2014 May;97(5):1610-5; discussion 1615-6. doi: 10.1016/j.athoracsur.2014.01.047. Epub 2014 Mar 15.
PubMed 24636706Gianoli M, de Jong AR, van der Harst P, van der Kaaij NP, Jacob KA, Suyker WJL. Cost Analysis of Robot-Assisted Versus On-Pump and Off-Pump Coronary Artery Bypass Grafting: A Single-Center Surgical and 30-Day Outcomes Comparison. Innovations (Phila). 2024 Jul-Aug;19(4):416-424. doi: 10.1177/15569845241269312. Epub 2024 Sep 12.
PubMed 39267423Michael Porter, Thomas Lee. The Strategy That Will Fix Healthcare. The Magazine.
Zhang S, Li P, Li G, Yan Y, Sun T, Lin J, Zhang C, Liu S, Qu Z, You B. Generalized hybrid coronary revascularization vs. conventional off-pump coronary artery bypass grafting for multivessel coronary artery disease. Front Cardiovasc Med. 2025 Feb 21;12:1459072. doi: 10.3389/fcvm.2025.1459072. eCollection 2025.
PubMed 40060966Harskamp RE, Vassiliades TA, Mehta RH, de Winter RJ, Lopes RD, Xian Y, Peterson ED, Puskas JD, Halkos ME. Comparative Effectiveness of Hybrid Coronary Revascularization vs Coronary Artery Bypass Grafting. J Am Coll Surg. 2015 Aug;221(2):326-34.e1. doi: 10.1016/j.jamcollsurg.2015.03.012. Epub 2015 Mar 20.
PubMed 25899734Patel PM, Arrington RL, Jonsson A, Wei JW, Binongo J, Devireddy C, Nicholson W, Jaber W, Rinfret S, Halkos ME. Advancing the Treatment Paradigm for Multivessel Coronary Artery Disease: Hybrid Coronary Revascularization. Innovations (Phila). 2025 Jan-Feb;20(1):57-64. doi: 10.1177/15569845241311292. Epub 2025 Feb 2.
PubMed 39894999Qu W, Wei J, Binongo JN, et al. Ischemic Heart Disease HYBRID CORONARY REVASCULARIZATION PROVIDES COMPARABLE LONG-TERM OUTCOMES TO CORONARY ARTERY BYPASS GRAFTING FOR PATIENTS WITH TWO-VESSEL CORONARY DISEASE. Vol 83.; 2024.
Xia Y, Katz AN, Forest SJ, Pyo RT, Greenberg MA, DeRose JJ Jr. Hybrid Coronary Revascularization has Improved Short-term Outcomes but Worse Mid-term Reintervention Rates Compared to CABG: A Propensity Matched Analysis. Innovations (Phila). 2017 May/Jun;12(3):174-179. doi: 10.1097/IMI.0000000000000376.
PubMed 28549028Harskamp RE, Puskas JD, Tijssen JG, Walker PF, Liberman HA, Lopes RD, Vassiliades TA, Peterson ED, Halkos ME. Comparison of hybrid coronary revascularization versus coronary artery bypass grafting in patients>/=65 years with multivessel coronary artery disease. Am J Cardiol. 2014 Jul 15;114(2):224-9. doi: 10.1016/j.amjcard.2014.04.028. Epub 2014 May 2.
PubMed 24878119Harskamp RE, Bagai A, Halkos ME, Rao SV, Bachinsky WB, Patel MR, de Winter RJ, Peterson ED, Alexander JH, Lopes RD. Clinical outcomes after hybrid coronary revascularization versus coronary artery bypass surgery: a meta-analysis of 1,190 patients. Am Heart J. 2014 Apr;167(4):585-92. doi: 10.1016/j.ahj.2014.01.006. Epub 2014 Jan 29.
PubMed 24655709Lowenstern A, Wu J, Bradley SM, Fanaroff AC, Tcheng JE, Wang TY. Current landscape of hybrid revascularization: A report from the NCDR CathPCI Registry. Am Heart J. 2019 Sep;215:167-177. doi: 10.1016/j.ahj.2019.06.014. Epub 2019 Jun 28.
PubMed 31349108
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MICRA-HYBRID Trial: A Randomized Controlled Trial of 'Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-Pump Coronary Artery Bypass Grafting'
- ClinicalTrials.gov ID
- NCT07314138
- Acronym / sponsor ID
- MICRA-HYBRID / NL-010448
- Conditions
- Coronary Artery Disease (CAD), Bypass, Cardiopulmonary, Minimally Invasive Coronary Revascularization Surgery, Off-pump Coronary Artery Bypass
- Keywords
- minimally invasive coronary surgery, percutaneous coronary intervention, off-pump coronary artery bypass grafting, hybrid coronary revascularization, heart surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Eindhoven University of Technology
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2034 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MICRA-HYBRID trial is a prospective, multicenter, randomized controlled study comparing multivessel hybrid coronary revascularization (HCR) as minimally invasive arterial bypass grafting to left-sided coronary targets (LAD and LCx) plus PCI of the RCA versus conventional off-pump coronary artery bypass grafting (OPCAB) via median sternotomy in patients with three-vessel coronary artery disease. The primary goal is to evaluate whether multivessel-HCR provides superior 30-day "textbook" clinical outcomes (mortality, MI, stroke, re-exploration for bleeding, and other complications) while improving perioperative recovery and long-term cardiovascular outcomes.
Detailed description
Coronary artery disease remains the leading cause of cardiovascular mortality worldwide. For complex, multivessel disease, surgical revascularization via CABG or OPCAB remains the guideline-recommended standard due to superior long-term outcomes compared with PCI alone. However, traditional sternotomy CABG/OPCAB is associated with significant surgical trauma, prolonged recovery, and elevated perioperative morbidity.
Minimally invasive coronary surgery (MICS) with off-pump arterial grafting through a small thoracotomy has shown favorable short-term recovery and lower morbidity in both single and multivessel disease cases. Traditionally, MICS has been limited to grafting the left anterior descending artery (LAD), with other coronary lesions treated by PCI, known as hybrid coronary revascularization (HCR). While most studies have focused on single-vessel HCR (typically LAD), the potential long-term benefits of including the circumflex (Cx) artery in a multivessel-HCR strategy remain unexplored. Given that three-vessel CAD is the most common indication for CABG, evaluating a multivessel-HCR approach (LAD + Cx via MICS, RCA via PCI) is essential.
The MICRA-HYBRID trial will randomize 250 patients with three-vessel coronary disease eligible for complete revascularization to either multivessel-HCR or conventional total-arterial OPCAB (median sternotomy, anaortic, off-pump). The primary efficacy endpoint is a composite "Textbook Outcome" at 30 days, defined by absence of death, MI, stroke, re-exploration for bleeding, and other major complications. Secondary endpoints include individual components of the Textbook Outcome, perioperative recovery parameters (ICU/hospital length of stay, ventilator time, transfusion requirement), health-related quality of life (EQ-5D), pulmonary recovery metrics, angina class (CCS), and long-term outcomes including MACCE and target-vessel revascularization up to five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dual center, superiority, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Multivessel hybrid coronary revascularization (HCR) | Active comparator | Procedure: Multivessel Hybrid Coronary RevascularizationMinimally invasive coronary artery bypass surgery to the left sided coronary vessels combined with percutaneous coronary intervention to the right coronary artery. |
| Off-pump coronary artery bypass grafting (OPCAB) | Active comparator | Procedure: Off-pump coronary arterial bypass grafting (OPCAB)Total arterial, anaortic off-pump ccoronary artery bypass grafting through median sternotomy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with three-vessel disease (either angiographic stenoses >70% or a fractional flow reserve value ≤0.80)
- Left main diameter stenosis ≥50% or a left main intravascular ultrasound minimal luminal area of ≤4.5 mm2 or fractional flow reserve value ≤0.80 combined with significant CAD of the right coronary artery
Key exclusion criteria (16 listed)
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Age < 18 or > 85 years
- Chronic total occlusion of the RCA
- In-stent RCA restenosis
- RCA stenosis with high-risk clinical features requiring urgent PCI or surgical revasculari-zation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivessel Hybrid Coronary RevascularizationMultivessel-HCR consists of MICS revascularization of the left sided coronary vessels (LAD , Cx) combined with PCI for the RCA during the same admission or within 4 weeks postoperatively. Surgical revascularization is performed through MICS which consists of either robotically or non-robotically assisted thoracoscopic IMA harvesting followed by total arterial off-pump anastomosis of the grafts through a left anterior 3-5 cm mini-thoracotomy. PCI will be performed via radial or femoral access according to local routine and is restricted to the RCA. | Procedure or surgery | Multivessel hybrid coronary revascularization (HCR) |
| Off-pump coronary arterial bypass grafting (OPCAB)OPCAB will be performed as per clinical routine at each center through a median sternotomy. IMA harvesting (pedicled or skeletonised) follows each center's routine. An anaortic, total arterial strategy with a LIMA-LAD graft and complete revascularisation is obliged. | Procedure or surgery | Off-pump coronary artery bypass grafting (OPCAB) |
Primary outcome
Composite Absence of Adverse Events within 30 Days Postoperatively (Textbook Outcome)
Time frame: 30 days postoperatively
The primary endpoint is defined as the "Textbook Outcome," which is the composite absence, within 30 days postoperatively, of the following events: * Mortality * Re-exploration for bleeding * Postoperative ischemia (requiring bypass grafting or acute PCI) * Postoperative myocardial infarction (type 5 MI according to the fourth universal definition of myocardial infarction) * Cardiac tamponade (requiring surgical or percutaneous intervention) * Cerebrovascular accident / transient ischemic attack * Wound infection requiring antibiotics or intervention * New-onset atrial fibrillation requiring medical anti-thrombotic therapy * Pneumonia requiring IV or oral antibiotics * Placement of additional chest drains * Prolonged hospital stay (> 7 days) after surgery
15 secondary outcomes
Conversion to Sternotomy
Time frame: Peri-operatively
Conversion to Cardiopulmonary Bypass
Time frame: Peri-operatively
Intensive Care Unit (ICU) Stay
Time frame: 30 days postoperatively
Postoperative Hospital Stay
Time frame: 30 days postoperatively
Mechanical Ventilation Time
Time frame: 30 days postoperatively
Postoperative Blood Loss
Time frame: 30 days postoperatively
Transfusion Requirement
Time frame: 30 days postoperatively
Phrenic Nerve Injury
Time frame: 30 days postoperatively
Postoperative Peak Expiratory Flow (PEF)
Time frame: 30 days postoperatively
Quality of Life Assessment (EQ-5D)
Time frame: 1 year
Angina Assessment (CCS Classification)
Time frame: 1 year
Short-term Healthcare Costs
Time frame: 30 days
Long-term Healthcare Costs
Time frame: 1 year
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: 5 years
Target Vessel Revascularization (TVR)
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 36940366van Steenbergen GJ, Schulz DN, Slingerland SR, Tonino PA, Soliman-Hamad MA, Dekker L, van Veghel D. Introduction of a New Method to Monitor Patient-Relevant Outcomes and Costs: Using a Quality Improvement Project in Transcatheter Aortic Valve Implantation Care as an Example. Qual Manag Health Care. 2023 Oct-Dec 01;32(4):247-256. doi: 10.1097/QMH.0000000000000401. Epub 2023 Mar 16.
- Background: PubMed 22958960Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction; Authors/Task Force Members Chairpersons; Thygesen K, Alpert JS, White HD; Biomarker Subcommittee; Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA; ECG Subcommittee; Chaitman BR, Clemmensen PM, Johanson P, Hod H; Imaging Subcommittee; Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ; Classification Subcommittee; Fox KA, Atar D, Newby LK, Galvani M, Hamm CW; Intervention Subcommittee; Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J; Trials & Registries Subcommittee; Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML; Trials & Registries Subcommittee; Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G; Trials & Registries Subcommittee; Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D; Trials & Registries Subcommittee; Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG); Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S; Document Reviewers; Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012 Oct 16;60(16):1581-98. doi: 10.1016/j.jacc.2012.08.001. Epub 2012 Sep 5. No abstract available.
- Background: PubMed 30153967Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.
- Background: PubMed 32998590Modrau IS, Nielsen PH, Nielsen DV, Christiansen EH, Hoffmann T, Parner ET, Benhassen LL. Outcome of hybrid compared to conventional revascularization in multivessel coronary artery disease. Scand Cardiovasc J. 2020 Dec;54(6):376-382. doi: 10.1080/14017431.2020.1821910. Epub 2020 Sep 30.
- Background: PubMed 24636706Halkos ME, Ford L, Peterson D, Bluestein SM, Liberman HA, Kilgo P, Puskas JD, Guyton RA, Chowdhury R. The impact of hybrid coronary revascularization on hospital costs and reimbursements. Ann Thorac Surg. 2014 May;97(5):1610-5; discussion 1615-6. doi: 10.1016/j.athoracsur.2014.01.047. Epub 2014 Mar 15.
- Background: PubMed 39267423Gianoli M, de Jong AR, van der Harst P, van der Kaaij NP, Jacob KA, Suyker WJL. Cost Analysis of Robot-Assisted Versus On-Pump and Off-Pump Coronary Artery Bypass Grafting: A Single-Center Surgical and 30-Day Outcomes Comparison. Innovations (Phila). 2024 Jul-Aug;19(4):416-424. doi: 10.1177/15569845241269312. Epub 2024 Sep 12.
- BackgroundMichael Porter, Thomas Lee. The Strategy That Will Fix Healthcare. The Magazine.
- Background: PubMed 40060966Zhang S, Li P, Li G, Yan Y, Sun T, Lin J, Zhang C, Liu S, Qu Z, You B. Generalized hybrid coronary revascularization vs. conventional off-pump coronary artery bypass grafting for multivessel coronary artery disease. Front Cardiovasc Med. 2025 Feb 21;12:1459072. doi: 10.3389/fcvm.2025.1459072. eCollection 2025.
- Background: PubMed 25899734Harskamp RE, Vassiliades TA, Mehta RH, de Winter RJ, Lopes RD, Xian Y, Peterson ED, Puskas JD, Halkos ME. Comparative Effectiveness of Hybrid Coronary Revascularization vs Coronary Artery Bypass Grafting. J Am Coll Surg. 2015 Aug;221(2):326-34.e1. doi: 10.1016/j.jamcollsurg.2015.03.012. Epub 2015 Mar 20.
- Background: PubMed 39894999Patel PM, Arrington RL, Jonsson A, Wei JW, Binongo J, Devireddy C, Nicholson W, Jaber W, Rinfret S, Halkos ME. Advancing the Treatment Paradigm for Multivessel Coronary Artery Disease: Hybrid Coronary Revascularization. Innovations (Phila). 2025 Jan-Feb;20(1):57-64. doi: 10.1177/15569845241311292. Epub 2025 Feb 2.
- BackgroundQu W, Wei J, Binongo JN, et al. Ischemic Heart Disease HYBRID CORONARY REVASCULARIZATION PROVIDES COMPARABLE LONG-TERM OUTCOMES TO CORONARY ARTERY BYPASS GRAFTING FOR PATIENTS WITH TWO-VESSEL CORONARY DISEASE. Vol 83.; 2024.
- Background: PubMed 28549028Xia Y, Katz AN, Forest SJ, Pyo RT, Greenberg MA, DeRose JJ Jr. Hybrid Coronary Revascularization has Improved Short-term Outcomes but Worse Mid-term Reintervention Rates Compared to CABG: A Propensity Matched Analysis. Innovations (Phila). 2017 May/Jun;12(3):174-179. doi: 10.1097/IMI.0000000000000376.
- Individual participant dataSharing planned: Undecided. IPD could be made available upon request to the Principal Investigator after the study's completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ferdi Akca, MD, PhD principal investigator
Catharina Ziekenhuis Eindhoven
Wouter Oosterlinck, Prof. Dr. MD, PhD study chair
Universitaire Ziekenhuizen KU Leuven
Pim Tonino, Prof. Dr. MD, PhD study chair
Catharina Ziekenhuis Eindhoven
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivessel Hybrid Coronary Revascularization and Off-pump coronary arterial bypass grafting (OPCAB) in people with Coronary Artery Disease (CAD) and Bypass, Cardiopulmonary, run by Catharina Ziekenhuis Eindhoven at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ferdi Akca, MD, PhD (+31 40 239 9111, ferdi.akca@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Absence of Adverse Events within 30 Days Postoperatively (Textbook Outcome) (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07314138, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.